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Senior Research Scientist I or II in Analytical Development

Website J-Star Research, Inc. J-Star Research, Inc.

J-STAR Research, Inc. operates as a contract research organization for pharmaceutical and biotechnology companies worldwide. It offers services in the areas of custom synthesis/contract research, process and analytical research, cGMP synthesis, crystallization process development, solid form screening and selection, pre/early formulation, and drug substance-drug product coprocessing.

Responsibilities:

  • Develop analytical methods and conduct the method validation. Ensure that methods are adequately documented, and that protocols and reports are correct and complete.
  • Conduct release testing for GMP raw materials, intermediates and final APIs.
  • Review test data to ensure completion and accuracy.
  • Troubleshoot and maintain analytical instruments.
  • Write SOPs, protocols, and reports as needed.
  • Train QC/AD and other applicable personnel on department procedures and test methods.
  • Conduct OOS and deviation investigations, as needed.
  • Support Quality Assurance as needed during internal audits and audits by clients and regulatory agencies. Assist in the development and implementation of corrective actions related to QC/AD.
  • Supervise quality control on API and/or intermediate within cGMP environment.
  • Supervise analytical method development and validation.
  • Supervise analytical support to the R&D chemists
  • Help ensure that client project needs, requirements, and timelines are communicated to the QC/AD group. Work with clients to develop or transfer test methods for materials used or supplied by J‑STAR.

Requirement Qualifications: 

  • MS or PhD in Chemistry, Pharmaceutical Science or related field.
  • 0-5 years of experience in analytical development and quality control
  • Good understanding of analytical chemistry and organic chemistry of small molecule drug substances.
  • Hands-on experience on HPLC/UV, LC/MS, MS, NMR, and other analytical instrument
  • Strong communication, organization, and planning skills.

How to Apply:

Resume can be emailed directly to: hui.chen@jstar-research.com. Be sure to denote the Job Title of the position you are applying.

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